A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.
研究概览
简要总结
This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female who is > 18 years old.
- •HIV-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
- •Currently on no treatment, or receiving treatment (< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
- •Positive CSF culture for Cryptococcus neoforman.
- •Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.
排除标准
- •Excluded for coma, or significant other medical conditions.
- •Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Mycograb + Amphotericin B + 5 flucytosine
干预措施: Efungumab (Mycograb) (Biological)
1
Mycograb + Amphotericin B + 5 flucytosine
干预措施: 5 flucytosine (Biological)
2
Placebo + Amphotericin B + 5 flucytosine
干预措施: placebo (Biological)
2
Placebo + Amphotericin B + 5 flucytosine
干预措施: 5 flucytosine (Biological)
3
Mycograb + Amphotericin B
干预措施: Efungumab (Mycograb) (Biological)
3
Mycograb + Amphotericin B
干预措施: Amphotericin B (Biological)
2
Placebo + Amphotericin B + 5 flucytosine
干预措施: Amphotericin B (Biological)
1
Mycograb + Amphotericin B + 5 flucytosine
干预措施: Amphotericin B (Biological)
结局指标
主要结局
proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.
时间窗: day 14
次要结局
- Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.(week 10)
- Assess the cerebrospinal fluid (CSF) penetration of Mycograb(Days 3, 7 and 14)
- Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.(Day 14)